Product class:
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Authorized package
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Medicinal product class:
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For human use
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Package code:
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1236046
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Name of medicinal product:
|
AMPRIL HL 2,5MG/12,5MG
|
Active substances:
|
|
ATC code:
|
C09BA84
|
Dosage form:
|
tablet
|
Route of administration:
|
oral use
|
Strengh:
|
2,5mg+12,5mg
|
Amount in package:
|
84TK
|
Legal status for supply*:
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Subject to medicinal prescription
|
Class of active substance:
|
|
Additional information:
|
|
Indication:
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Treatment of hypertension.
This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or hydrochlorothiazide alone.
|
Safety features:
|
Yes
|
Summary of product characteristics (SPC):
|
(last updated April 21, 2023)
|
Package information leaflet (PIL):
|
EST (last updated April 21, 2023)
|
Labelling:
|
(last updated April 21, 2023)
|
Last imported to Estonia:
|
Never imported to Estonia
|
Marketing authorization holder:
|
KRKA, d.d., Novo mesto
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Marketing authorization number:
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497005
|
Marketing authorization issued on:
|
November 11, 2005
|
Marketing authorization expires on:
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Unlimited
|
Marketing authorization procedure type:
|
Mutual recognition
|
Reference price:
|
|
Under reference price:
|
|
Reference price of daily dose:
|
|
Description
|
Additional condition
|
Perearsti õel on õigus välja kirjutada
|
Välja arvatud esmane retsept
|
Entry/Changing date:
March 4, 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription
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